The invention relates to a pack for pharmaceutical and/or medical products and/or food supplements, comprising a substrate which is fitted with one or more prefabricated, sealed product carriers which each contain one or more isolated products, for a given length of time, and is provided with instructions for application or administration time for the patient, each product carrier exclusively containing products of a special active ingredient or a special combination of active ingredients in a special dosage. Furthermore, the invention relates to a method and an apparatus for the manufacture of these packs.
For the primary packings of pharmaceutical and/or medical products and/or food supplements (which are hereinafter also referred to as products), for example one might mention tablets, dragées, ampoules, vitamin preparations but also syringes or the like, different requirements are important. On the one hand there are constant endeavours to make it easier for patients to take the drugs or apply the products. In addition to easier removal of the product from the pack by corresponding removal aids, the packs existing for this purpose also assist the patients with the dosage and when to take the drugs. These aspects are usually known under the keywords “convenience” or “senior-friendliness” (SF). On the other hand the aspect concerning child safety, so-called child resistance (CR), is of increasing importance under regulations. The common packs are therefore protected by various measures against unauthorised removal in particular by children.
It is, however, precisely in the case of pharmaceutical and/or medical products that the reliability of keeping the prescribed drugs is of particular importance, which is to be assisted by the so-called compliance packs. It has been shown that patients take the drugs prescribed for them more reliably if one or more and/or various drugs are arranged adjacent to each other or together within one pack and the necessary times of application or taking are described by calendar and time data. For instance, gastric protection preparations are to be taken simultaneously in addition to antibiotics. Arranging or assembling the drugs according to day of the week and time of day makes it easier for the patient to take his prescribed drugs reliably, which is of particular importance in particular for chronically ill patients.
Packs which ensure assembly of one or more products individually to the patient are known and available on the market. Thereby, the products are either put directly as raw materials or, after removal from a package, into the corresponding packs individual to the patient, e.g. in compartments of packaging units. However, this presupposes firstly that this must be done under defined clean-room conditions and with pharmaceutical experts, which leads to very high costs. Secondly, partly manual removal and repackaging is susceptible to error, laborious and expensive due to the large number of steps to be taken, and furthermore also leads to mechanical stress on the products. Moreover, the packaging of drugs from raw materials and the handling of raw materials after removal from the package require special basic legal conditions which take considerable effort to fulfil. With the known packs made by the methods described above, under certain circumstances several different products/tablets are arranged in a holding chamber, e.g. a bag, a tubular bag, a nest of a blister pack or the like. However, this is disadvantageous in particular due to the risk of cross-contamination. To avoid such cross-contamination there are endeavours to place the products each individually in the closed state on a pack. This means that the products are arranged separately in a compartment of a packaging unit or a nest of the blister pack and, packed in this way, are to be assembled into a pack intended for the patient.
From EP 0 852 208 A1 a tablet container is also known having the features of the preamble of claim 1. This pack has a substrate on which several isolated products are arranged in sealed product carriers, wherein the dosage of the same active ingredient or the same combination of active ingredients for the treatment of Parkinson's disease increases gradually (first day one tablet, second day one tablet, third day two tablets, fourth day three tablets, etc.). The products are prefabricated in sheet-like blisters. Such blisters thereby have several columns and several rows, for example as 2×5 blisters. This means that the products are each located individually in sealed nests of the blister tray/blister magazine. Sealed in this context means that each product within the nest is surrounded on all sides in relation to the environment, so that the products are protected from external influences (mechanical stress or other contamination, in particular biological or chemical contamination). Product carriers separated off from the blister tray/blister magazine can in this case contain one or more isolated products. These product carriers are then assembled into a treatment-specific pack. Besides the disadvantage of purely treatment-specific assembly of the products just discussed, automated production of such a pack is possible only with unreasonable effort because e.g. separation of individual product vehicles from a flat, multi-row blister tray must be carried out in different directions. To sum up, the pack described in the above European patent document is assembled exclusively for a specific treatment and can be manufactured automatically only uneconomically.